(20 days)
The Synthes 4.5 mm and 6.5 mm Headless Compression Screws are indicated for fracture fixation, reconstruction, osteotomy, and arthrodesis of various bones and bone fragments including joint fusions (arthrodeses) in the foot and fixation of intra-articular fractures of the humerus, femur and tibia.
Synthes 4,5 mm and 6,5 mm Headless Compression Screws are cannulated and are self-drilling/self tapping, feature a StarDrive recess, and have a threaded head which can be countersunk into the bone. They are available in stainless steel and titanium alloy, in a variety of lengths.
The provided text is a 510(k) summary and FDA clearance letter for a medical device (Synthes 4.5 mm and 6.5 mm Headless Compression Screws). This type of document is a regulatory submission for a medical device and does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance testing documentation for software/AI devices.
The 510(k) process demonstrates substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a dedicated study.
Therefore,Based on the provided text, I cannot extract any information regarding:
- Acceptance criteria and reported device performance table: The document does not specify performance acceptance criteria or report performance metrics in this format.
- Sample size and data provenance for a test set: No test set is described.
- Number and qualifications of experts for ground truth: No such experts are mentioned.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
This document focuses on the description of the device, its intended use, classification, and its substantial equivalence to predicate devices to obtain FDA clearance, not on a detailed study proving its performance against acceptance criteria.
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Page _________________________________________________________________________________________________________________________________________________________________________ 510(k) Summary Synthes (USA) Sponsor: 1301 Goshen Parkway West Chester, PA 19380 APR 2 3 2008 (610) 719-6940 Sheri L. Musgnung Contact: Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 (610) 719-6940 FAX (610) 484-356-9682 Device Name: Synthes 4.5 mm and 6.5 mm Headless Compression Screws Classification; Class II, §888.3040 - Smooth or threaded metallic bone fixation fastener. Predicate Device: Synthes 4.5 mm Cannulated Screws Synthes 6.5 mm Cannulated Screws OsteoMed's Headless Cannulated Screw System Device Description: Synthes 4,5 mm and 6,5 mm Headless Compression Screws are cannulated and are self-drilling/self tapping, feature a StarDrive recess, and have a threaded head which can be countersunk into the bone. They are available in stainless steel and titanium alloy, in a variety of lengths. Intended Use: The Synthes 4.5 mm and 6.5 mm Headless Compression Screws are indicated for fracture fixation, reconstruction, osteotomy, and arthrodesis of various bones and bone fragments including joint fusions (arthrodeses) in the foot and fixation of intra-articular fractures of the humerus, femur and tibia. Substantial Information presented supports substantial equivalence. Equivalence:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 2008
Synthes (USA) % Ms. Sheri Musgnung 1301 Goshen Parkway West Chester, PA 19380
Re: K080943 Trade/Device Name: Synthes 4.5 mm and 6.5 mm Headless Compression Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: April 2, 2008 Received: April 3, 2008
Dear Ms. Musgnung:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Sheri Musgnung
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K080943 510(k) Number (if known): Synthes 4.5 mm and 6.5 mm Headless Compression Screws Device Name: Indications for Use; The Synthes 4.5 mm and 6.5 mm Headless Compression Screws are indicated for fracture fixation, reconstruction, osteotomy, and arthrodesis of various bones and bone fragments including joint fusions (arthrodeses) in the foot and fixation of intraarticular fractures of the humerus, femur and tibia. Over-The-Counter Use X AND/OR Prescription Use (21 CFR 807 Subpart C) (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Ogle for nxn
(Division Si Division of General, Restorative, and Neurological Devices
510(k) Number K080943
L
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.